MAUDE Adverse Event Report: COVIDIEN ELECTRODE Q TRACE GOLD 5500 ECL BULK; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	30807732
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: during an ophthalmological examination, the patient had to have the diagnostic patches glued to the face.After the examination when the patches were removed one of the patches ripped the skin off the patient's face.The current status of the patient is an open wound and 5 stitches.Per additional information received on 24jun2019, the patient is a (b)(6) yr old male, dob (b)(6).No recent measurement of weight.Medical history not available.Race not available.The electrodes were placed on the patient¿s face during an electroretinogram.It is unknown which machine was used.The duration of the procedure (examination time) and how long the electrodes were on the patient's face is unknown.

• Brand Name: ELECTRODE Q TRACE GOLD 5500 ECL BULK
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 8732591
• Report Number: 1219103-2019-00236
• Device Sequence Number: 19475968
• Product Code: DRX
• UDI-Device Identifier: 20884527002723
• UDI-Public: 20884527002723
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 30807732
• Device Catalogue Number: 30807732
• Device Lot Number: 734239X
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR